Medical Device Safety Data Management
Medical device safety management is the process of identifying and managing potential risks associated with the use of medical devices. The aim is to ensure that the medical devices are safe for patients and healthcare providers. This process includes a range of activities such as design, manufacturing, packaging, labeling, distribution, and post-market surveillance.
There are several regulations and standards that outline the requirements for medical device safety management. For example, the ISO 14971 standard provides guidance on risk management for medical devices, and the FDA has established regulations for medical devices to ensure their safety and effectiveness.
With over 15+ years experience, our medical writing team has helped several pharma and medical device companies by delivering clinical, non-clinical, regulatory, and post-marketing related medical writing services with the following principles:
- Ensuring accuracy and completeness of information
- Drafting content as per latest regulatory guidelines
- Effectively communicating complex information
- Applying latest methods in scientific research
- Leveraging latest technology for content creation
- Always meeting timelines and avoiding delays
How We Can Help
Adverse Event Reporting
We provide end-to-end management of the incident reporting process to expertly determine severity and expedite reporting of serious incidents in compliance with regulations for devices across all classes.
Safety Signal Management
Our safety team can assist with signal detection methods and systematic assessments (i.e. quantitative methods) to identify safety signals, for the implementation of required risk mitigation plans
Literature Monitoring
Our literature monitors review articles from global and local databases to identify potential incident reports and classify them for further analyses.
Medical Writing
Our highly-trained medical writing teams author and submit high-quality periodic reports across the product’s lifecycle to meet guidelines prescribed by health authorities.
Regulatory Submissions
Manage regulatory documents preparation and submissions, including creating and updating regulatory dossiers, tracking submission status, and maintaining records of submissions and approvals.
Medical Device Call Center
Our product and safety specialists provide call center services around the clock to monitor adverse events and product complaints before expertly disseminating information to all stakeholders efficiently and on time.